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Corticosteroid

Intra-articular Injections for Shoulder Osteoarthritis (GHOA Trial)

N/A

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline pain level of VAS greater than 4

Patient must be 18 years or older

Must not have

Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis)

Ipsilateral shoulder surgery within 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two treatments for shoulder osteoarthritis to see which one is more effective to give relief and delay/avoid surgery.

Who is the study for?

This trial is for adults over 18 with primary glenohumeral osteoarthritis, which means they have significant shoulder joint pain and damage seen on X-rays. They must be experiencing a baseline pain level of more than moderate intensity. People who've had recent shoulder surgery, are pregnant, involved in workers' compensation cases for the shoulder, or have other types of arthritis or allergies to lidocaine can't participate.

What is being tested?

The study aims to see if corticosteroid injections into the shoulder joint work better than platelet-rich plasma (PRP) injections for treating primary glenohumeral osteoarthritis without surgery. It's testing whether these treatments can relieve symptoms enough to delay or avoid shoulder replacement surgery.

What are the potential side effects?

Possible side effects from the injections may include temporary increase in pain, infection at the injection site, allergic reactions to components like lidocaine, weakening of nearby bones or tendons, and less commonly systemic effects related to corticosteroids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level is more than 4 on a scale of 0-10.

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I am 18 years old or older.

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I have been diagnosed with shoulder arthritis through X-rays and doctor's exams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My arthritis is not caused by infections, injuries, or other specific conditions.

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I had shoulder surgery on the same side within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analog Scale-Pain (VAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Corticosteroid Injection GroupExperimental Treatment1 Intervention

80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection

Group II: Platelet-Rich Plasma Injection GroupActive Control1 Intervention

15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP

0 / 5Eligibility criteria met